Shreenanda Jois
Quality Assurance Auditor II
Experience
Quality Assurance Auditor II
ICON Plc.
- Planned, conducted, and reported on risk-based technical GCP and GLP audits (investigator site, affiliate, and study-level).
- Reviewed and audited computerized systems, software qualification, and validation protocols for regulatory compliance.
- Led or supported end-to-end vendor/supplier audits, regulatory/client audits, and inspections, ensuring robust inspection readiness and compliance gap resolution.
- Leveraged AI tools to streamline workflows, automate processes, and support data-driven decision-making for operational efficiency.
- Supported regional quality expertise to ensure compliance with local regulatory requirements.
- Guided clinical trial teams in quality issue management activities, including CAPAs, inspection readiness, serious breaches, and privacy issues.
- Managed Quality Management System (eQMS) activities: change control, audit management, deviation management, CAPA, and RCA.
- Supported investigations, RCA, and CAPA management for quality issues and external audit/inspection findings.
- Provided input to global quality compliance data, metrics, and quality index data.
- Reviewed client database applications, database design, and data validation tools per protocols/plans.
- Ensured regulatory compliance and quality assurance responsibilities for clinical trials.
Quality Assurance Executive
Syngene International Ltd.
- Prepared and reviewed global SOPs, policies, protocols, and documents in adherence to regulatory guidelines.
- Managed QMS activities: change control, audit management, deviation management, CAPA, and RCA.
- Reviewed and audited bioanalytical data (pharmacokinetics, immunogenicity, biomarker studies) for data integrity and compliance.
- Planned and conducted internal/external audits and reviews for quality, facility, safety, and efficacy studies.
- Provided training and guidance on regional and global regulations; contributed to quality system improvements.
Summary
6+ years of experience in Quality Assurance, Computerized System Validation (CSV), and GxP global quality compliance within the pharmaceutical/biotech industry. Strong knowledge of GxP regulations, including USFDA 21 CFR Part 11/820, EU Annex 11, ISO 13485/17025, OECD GLP, ICH-GCP, EMA, GDP, and WHO GCLP guidelines. Expertise in risk-based quality issue management, audit planning, regulatory inspection readiness, and data integrity for clinical trials.
Skills
Gcp, Glp, Gclp, Gdp Compliance
Computerized System Validation (Csv)
Quality Management Systems (Qms, Eqms)
Risk Assessment & Mitigation (Ract)
Regulatory Inspection & Audit Management
Capa & Root Cause Analysis (Rca)
Data Integrity & Clinical Data Review
Sop & Quality Manual Development
Ai Tools For Process Automation
Cross-functional Team Leadership
Veeva Vault, Trackwise (Eqms)
Microsoft Office Suite (Word, Excel, Powerpoint)
Audit Management Tools
Excellent Interpersonal, Verbal, And Written Communication Skills.
Ability To Work Independently And Across Functional/geographical Boundaries.
Strong Mentoring And Leadership Skills For Qa Staff.
Process Improvement Mindset; Focus On Efficiency And Compliance.
Effective Representation Of Data And Quality Analytics In Cross-functional Initiatives.
Languages
Education
University of Mysore
Master’s in Biochemistry · Biochemistry · Mysuru, India
University of Mysore
Bachelor’s in Biochemistry, Microbiology, and Biotechnology · Biochemistry, Microbiology, and Biotechnology · Mysuru, India
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